Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 12:57 PM
Study NCT ID:
NCT00099567
Status:
COMPLETED
Last Update Posted:
2005-11-01
First Post:
2004-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'NATURAL_HISTORY'}, 'enrollmentInfo': {'count': 2632}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-12', 'completionDateStruct': {'date': '2002-12'}, 'lastUpdateSubmitDate': '2005-10-31', 'studyFirstSubmitDate': '2004-12-16', 'studyFirstSubmitQcDate': '2004-12-16', 'lastUpdatePostDateStruct': {'date': '2005-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-17', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', "Alzheimer's Disease", 'Cognitive Impairment', 'Inflammation'], 'conditions': ['Cognitive Decline']}, 'referencesModule': {'references': [{'pmid': '12847160', 'type': 'BACKGROUND', 'citation': 'Yaffe K, Lindquist K, Penninx BW, Simonsick EM, Pahor M, Kritchevsky S, Launer L, Kuller L, Rubin S, Harris T. Inflammatory markers and cognition in well-functioning African-American and white elders. Neurology. 2003 Jul 8;61(1):76-80. doi: 10.1212/01.wnl.0000073620.42047.d7.'}, {'pmid': '11031212', 'type': 'BACKGROUND', 'citation': 'Kalmijn S, Foley D, White L, Burchfiel CM, Curb JD, Petrovitch H, Ross GW, Havlik RJ, Launer LJ. Metabolic cardiovascular syndrome and risk of dementia in Japanese-American elderly men. The Honolulu-Asia aging study. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2255-60. doi: 10.1161/01.atv.20.10.2255.'}, {'pmid': '15536110', 'type': 'RESULT', 'citation': 'Yaffe K, Kanaya A, Lindquist K, Simonsick EM, Harris T, Shorr RI, Tylavsky FA, Newman AB. The metabolic syndrome, inflammation, and risk of cognitive decline. JAMA. 2004 Nov 10;292(18):2237-42. doi: 10.1001/jama.292.18.2237.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation.', 'detailedDescription': 'The metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure, and insulin resistance. This study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood.\n\nThis 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. A total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the Health, Aging and Body Composition (ABC) study conducted during the same period. Participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 70 to 79\n* White or Black\n* Community-dwelling in Memphis, TN or Pittsburgh, PA vicinity\n* Well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting)\n\nExclusion Criteria:\n\n* Any difficulty with activities of daily living\n* Clinical dementia\n* Inability to communicate with interviewer\n* Intention of moving out of vicinity in the next year\n* Active treatment for cancer in the previous 3 years\n* Participation in a trial involving a lifestyle intervention'}, 'identificationModule': {'nctId': 'NCT00099567', 'briefTitle': 'Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Aging (NIA)'}, 'officialTitle': 'Metabolic Syndrome, Inflammation, and Risk of Cognitive Decline', 'orgStudyIdInfo': {'id': 'IA0066'}, 'secondaryIdInfos': [{'id': '1N01AG062106', 'link': 'https://reporter.nih.gov/quickSearch/1N01AG062106', 'type': 'NIH'}, {'id': '1R01AG021918', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG021918', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Kristine Yaffe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, 'collaborators': [{'name': 'Paul Beeson Faculty Scholars Program', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}]}}}